01 1Chemi SpA
01 1AICA HYDROCHLORIDE
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14013
Submission : 1999-03-05
Status : Active
Type : II
A 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride, including repackagers and relabelers. The FDA regulates 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride supplier is an individual or a company that provides 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride active pharmaceutical ingredient (API) or 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride finished formulations upon request. The 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride suppliers may include 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride active pharmaceutical ingredient (API) in detail. Different forms of 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride DMFs exist exist since differing nations have different regulations, such as 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride USDMF includes data on 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride suppliers with USDMF on PharmaCompass.
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